Russian Extremely Severe Ulcerative Colitis Study

NCT ID: NCT03947931

Last Updated: 2022-08-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 71 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-20
• Study Completion Date: 2022-06-20

Brief Summary

The purpose of this study is prove the need to selection of a extremely severe ulcerative colitis, to identify predictors of colectomy, which will reduce the optimal time for surgery.

Detailed Description

Acute severe ulcerative colitis is a life threatening disease,total mortality rate can reach 17%, and the frequency of surgical treatment approximately 40%. Standard conservative therapy in these patients is often ineffective and the optimal timing of the surgical treatment has not yet been established.

In the Russian clinical guidelines for the treatment of ulcerative colitis, the extremely severe ulcerative colitis is added to the classification of the severity.

The extremely severe ulcerative colitis is a severe, according to the criteria of Truelove, Witts and the endoscopic picture of deep, extensive ulcerative defects of the mucosa, up to the muscular layer with the formation of mucosal islets including albumin reduction.

Conservative treatment of patients with extremely severe ulcerative colitis worsens treatment outcomes only. The authors of the study want to prove that patients with a extremely severe ulcerative colitis need a colectomy in a short time.

Is there a need for long-term follow-up, conservative treatment of high-risk patients? Is it safe to perform early surgical treatment without long-term conservative treatment? This study will allow to answer these questions and help doctors in the treatment of such patients anywhere in Russia and not only.

Conditions

Ulcerative Colitis; Inflammatory Bowel Diseases

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

General group

Patient with extremely severe ulcerative colitis

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Acute Severe Colitis according to the Truelove and Witt's Criteria;
• Extremely severe activity according endoscopic picture of deep, extensive ulcerative defects of the mucosa, up to the muscular layer with the formation of mucosal islets including albumin reduction (lower 31 g/l).

Exclusion Criteria

• Pregnancy;
• Infectious, ischemic colitis;
• Transformation of diagnosis into Crohn's disease;
• Medical treatment failure before the admission.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State Scientific Centre of Coloproctology, Russian Federation

OTHER_GOV

Sponsor Role: lead

Responsible Party

Achkasov Sergey

Achkasov Sergey, Professor of State Scientific Centre of Coloproctology, Head of sugery and oncology of colon department, Moscow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayrat Mingazov

Role: STUDY_CHAIR

Sub-investigator

Locations

State Scientific Centre of Coloproctology, Russian Federation

Moscow, , Russia

Countries

Russia

Other Identifiers

127

Identifier Type: -

Identifier Source: org_study_id